Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Small Intestine Cancer
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, recurrent mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent adult Hodgkin lymphoma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, adult nasal type extranodal NK/T-cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, small intestine lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma OR any of the following high-risk lymphomas:
Diffuse large B-cell lymphoma meeting any of the following criteria:
- Failed induction therapy but responded to salvage therapy
- Relapsed < 1 year after completion of induction therapy
- Elevated lactic dehydrogenase (LDH) at relapse
- Stage III or IV disease at relapse
- Positive PET scan after induction or salvage therapy
- Age 60 to 75 years
Follicular lymphoma meeting any of the following criteria:
- Progressive disease after two or more prior regimens
- Transformed to aggressive diffuse large B-cell lymphoma but is still chemotherapy sensitive
- Not considered to be a good candidate for allogeneic stem cell transplantation
Hodgkin lymphoma meeting any of the following criteria:
- Primary refractory disease
- Relapsed < 1 year after completion of induction therapy
- Relapsed with PET positive disease after salvage therapy
- Relapsed refractory disease and is not considered to be a good candidate for allogeneic stem cell transplantation
Mantle cell lymphoma meeting any of the following criteria:
- Chemotherapy sensitive disease after induction therapy
- Chemotherapy sensitive relapsed disease and is not considered to be a good candidate for allogeneic stem cell transplantation
T-cell non-Hodgkin lymphoma (NHL) meeting any of the following criteria:
Peripheral T-cell lymphoma, not otherwise specified meeting at least one of the following criteria:
- High LDH at diagnosis
- Marrow involvement at diagnosis
- Age > 60 years at diagnosis
- Low platelet count at diagnosis
- Chemotherapy sensitive relapsed disease
- Angioimmunoblastic lymphadenopathy with dysproteinemia
- ALK-negative anaplastic NHL
- Enteropathy-associated T-cell NHL
- Stage III or IV NK-/T-cell NHL at diagnosis
- NK-blastic NHL
- Has undergone autologous hematopoietic stem cell transplantation and received 200 mg/m² of melphalan (for multiple myeloma) OR BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and methotrexate (for high-risk lymphoma) as conditioning therapy
PATIENT CHARACTERISTICS:
- ECOG or WHO performance status 0-2
- ANC ≥ 1,000/μL
- Platelet count ≥ 75,000/μL
- Total bilirubin ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 2 times the ULN
- Not pregnant or nursing
- No severe or uncontrolled systemic illness
No "currently active" second malignancy, other than nonmelanoma skin cancer or carcinoma in situ of the cervix
- Patients are not considered to have a "currently active" malignancy if they completed therapy for the malignancy, are disease free from the malignancy for > 5 years, and are considered by their physician to be at < 30% risk of relapse
No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:
- Uncontrolled hypertension
- Unstable angina
- Recent myocardial infarction (within the past 6 months)
- Uncontrolled congestive heart failure
- No active bacterial, fungal, or viral infection
- No known HIV infection or active hepatitis B and/or hepatitis C infection
- No other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results
PRIOR CONCURRENT THERAPY:
- No concurrent biologic therapy, chemotherapy, or other antineoplastic therapy
Sites / Locations
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Prevnar
The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.